cGMP Facility Design for WuXi AppTec’s Advanced Manufacturing Center
Genesis played a pivotal role in helping WuXi AppTec realize their vision for an advanced cGMP center design.
We provided our architectural and engineering excellence to create a modern pharmaceutical manufacturing facility that is designed to comply with international standards set by ICH, EMA, PIC/S, and FDA.
Customized cGMP Facility Design to Accommodate Diverse Production Technologies
The cGMP center design which accommodates a range of production technologies, from conventional methods like roller bottles to advanced systems such as wave bags and single-use bioreactors, was designed with two main floors catering to specific needs. The first floor focused on autologous cell therapy, while the second floor was optimized for BSL-2 viral vector production.
H2: Clean Room Design and Engineering for Sterile Manufacturing
Our team also established clean rooms conforming to EU Grades B-D for varying levels of sterility. Essential support systems like water for injection, clean dry air, and gases were integrated, alongside a robust environmental monitoring setup.
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Glossary
- cGMP (Current Good Manufacturing Practices): Regulatory guidelines ensuring products are consistently produced and controlled according to quality standards.
- ICH, EMA, PIC/S, FDA: Respective international regulatory bodies or guidelines governing drug development and safety.
- BSL-2 (Biosafety Level 2): A safety level in biohazard labs that handle agents that can cause human disease but are typically not airborne.
- WFI (Water For Injection): Water that is purified by distillation or a purification process that is equivalent to distillation.
- CDA (Clean Dry Air): Air that is free of contaminants and moisture.
- RO/DI (Reverse Osmosis/Deionized): A method for purifying water using a semi-permeable membrane.
